Module 12 2019

IDMP and Pharmacovigilance

• Enable patients or HCPs to report adverse events linked directly to the specific pack that was dispensed – by scanning the code on the pack • This could improve pharmacovigilance data analysis and signal detection by enriching the data provided with patient-or HCP-reported ICSRs o Identify batch, dose, manufacturer, excipients, etc

o Easily identify MAH for generics

The Organisation for Professionals in Regulatory Affairs